The purpose of this study is to evaluate the effects of single and multiple doses of ABCL635 administered by subcutaneous (SC) injection to healthy men and to postmenopausal women with or without any vasomotor symptoms (VMS) or hot flashes, and to postmenopausal women with moderate-to-severe VMS associated with menopause. The safety, tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) parameters of ABCL635 will be assessed in all study participants; the effects on frequency and severity of VMS will be assessed in postmenopausal women who experience moderate-to-severe symptoms.
The study consists of 3 parts. In Part A, single ascending doses (SAD) of ABCL635 or placebo will be administered to healthy male and female participants. In Part B, up to 3 multiple ascending doses (MAD) of ABCL635 or placebo will be administered to healthy postmenopausal women with or without VMS. In Part C, a single dose of ABCL635 or placebo will be administered to postmenopausal women experiencing moderate-to-severe VMS associated with menopause. Part C participants receiving placebo will be offered to participate in an open label extension (OLE) cohort and receive a single dose of ABCL635 upon completion of a 12-week assessment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
136
Mount Saint Joseph Hospital Clinical Trials Phase 1 Unit
Vancouver, British Columbia, Canada
RECRUITINGCentricity Research
Toronto, Ontario, Canada
RECRUITINGCentricity Research
Toronto, Ontario, Canada
RECRUITINGAltasciences Company Inc.
Mount Royal, Quebec, Canada
RECRUITINGClinique RSF Inc.
Québec, Quebec, Canada
RECRUITINGDiex Recherche Sherbrooke
Sherbrooke, Quebec, Canada
RECRUITINGDiex Recherche Trois-Rivières
Trois-Rivières, Quebec, Canada
RECRUITINGDiex Recherche Victoriaville
Victoriaville, Quebec, Canada
RECRUITINGFrequency and severity of adverse events (AE)
Time frame: Day 0 to day 197
Number of participants with abnormalities in 12-lead safety electrocardiograms (ECG)
Time frame: Day 0 to day 197
Number of participants with abnormalities in physical examination
Time frame: Day 0 to day 197
Number of participants with abnormalities in laboratory parameters, including general biochemistry, hematology, endocrinology, and urinalysis
Time frame: Day 0 to day 197
Plasma concentrations of ABCL635
Time frame: Day 0 to day 197
Incidence of anti-ABCL635 antibodies
Time frame: Day 0 to day 197
PK parameters; maximum plasma concentration (Cmax)
Time frame: Day 0 to day 197
PK parameters; time to maximum plasma concentration (Tmax)
Time frame: Day 0 to day 197
PK parameters; area under the plasma concentration-time curve from zero to the time of the last quantifiable concentration (AUC0-T)
Time frame: Day 0 to day 197
PK parameters; area under the plasma concentration-time curve from zero to hour 672 (AUC0-672)
Time frame: Day 0 to day 197
PK parameters; area under the plasma concentration-time curve from zero to infinity (AUC0-∞)
Time frame: Day 0 to day 197
PK parameters; percent of AUC obtained by extrapolation (%AUCextrap)
Time frame: Day 0 to day 197
PK parameters; terminal rate constant (λz)
Time frame: Day 0 to day 197
PK parameters; apparent plasma clearance of drug after extravascular administration (CL/F)
Time frame: Day 0 to day 197
PK parameters; apparent volume of distribution after extravascular administration (Vz/F)
Time frame: Day 0 to day 197
PK parameters; half-life (Thalf)
Time frame: Day 0 to day 197
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